TOSHIBA 3T EXTRA LARGE KNEE COIL


Device Classification Name

coil, magnetic resonance, specialty

510(k) Number K112313
Device Name TOSHIBA 3T EXTRA LARGE KNEE COIL
Applicant
QUALITY ELECTRODYNAMICS
700 beta dr.
suite 100
mayfield village, 
OH 
44143

Applicant Contact christie zydyk
Correspondent
QUALITY ELECTRODYNAMICS
700 beta dr.
suite 100
mayfield village, 
OH 
44143

Correspodent Contact christie zydyk
Regulation Number 892.1000
Classification Product Code
MOS  
Date Received 08/11/2011
Decision Date 09/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No